Familial Mediterranean FeverNCT07129538
Outcomes of Inspiratory Muscle Training in FMF Adolescents
A study testing inspiratory muscle retraining and colchicine only in people with Familial Mediterranean Fever, run by Cairo University at 1 site in Egypt.
Trial summary
Familial mediterranean fever (FMF) is common to be diagnosed before age of 18 . this disorder is connected with deterioration in exercise tolerance, pulmonary capacities, fatigue tolerance, Read more about this study
- Who is it for?
- Ages 13 to 17 years
- Conditions the study is for
- Familial Mediterranean Fever
- What is being tested?
- inspiratory muscle retraining and colchicine only
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 10 May 2025to 15 Sep 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- FMF adolecents
- ages 13 -17 years
- forty patients
Who cannot join
- cardiac problems
- renal problems
- liver problems
- diabetes
- brain problems
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Ismail, lecturer contact
Egypt1 site, 1 recruiting
- Recruiting
Faculty of physical therapy
Giza, Dokki
ali ismail, lecturer, 02 01005154209, ali.mohamed@pt.cu.edu.eg
About this study
Familial mediterranean fever (FMF) is common to be diagnosed before age of 18 . this disorder is connected with deterioration in exercise tolerance, pulmonary capacities, fatigue tolerance,
Read the detailed description
Familial mediterranean fever (FMF adolescents ) will be collected to be cateogarized to inspiratory muscle retraining group (IMR group) or control waitlist grouping. every group OF FMF will contain 20 FMF adolescents. IMR group will receive two IMR sessions daily, five times weekly, for eight weeks (every IMR session will contain 3 sets of IMR and the set will contain 10 breath cycles).. both groups will receive their prescribed colchicine medications daily
- Conditions
- Familial Mediterranean Fever
- Being tested
- inspiratory muscle retraining, colchicine only
- Medical subject headings
- Familial Mediterranean Fever
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
inspiratory muscle retrainingOther
Familial mediterranean fever (FMF adolescents ) will be inspiratory muscle retraining group (IMR group) that will contain 20 FMF adolescents. IMR group will receive two IMR sessions daily, five times weekly, for eight weeks (every IMR session will contain 3 sets of IMR and the set will contain 10 breath cycles).. this group will receive their prescribed colchicine medications daily
colchicine onlyOther
Familial mediterranean fever (FMF adolescents ) will be collected in this group OF FMF that will contain 20 FMF adolescents. this group will receive their prescribed colchicine medications daily for eight weeks
| Study group | Role | What they receive |
|---|---|---|
| IMR group | Experimental | Familial mediterranean fever (FMF adolescents ) in this inspiratory muscle retraining group (IMR group) will contain 20 FMF adolescents. IMR group will receive two IMR sessions daily, five times weekly, for eight weeks (every IMR session will contain 3 sets of IMR and the set will contain 10 breath cycles).. also this group will receive their prescribed colchicine medications daily Receives: Other: inspiratory muscle retraining |
| control group | Other | Familial mediterranean fever (FMF adolescents ) will be group of FMF will contain 20 FMF adolescents. this group will receive their prescribed colchicine medications daily Receives: Other: colchicine only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Multidimensional Scale of Fatigue extracted from total score of pediatric quality of life
it will assess fatigue perception
Measured: it will be measured after 8 weeks
Secondary outcomes (10)
cognitive fatigue subscale of Multidimensional Scale of Fatigue related pediatric quality of life
it will assess cognitive fatigue perception
Measured: it will be measured after 8 weeks
sleep and rest fatigue subscale of Multidimensional Scale of Fatigue related pediatric quality of life
it will assess fatigue perception during sleep and rest
Measured: it will be measured after 8 weeks
general fatigue subscale of Multidimensional Scale of Fatigue related pediatric quality of life
it will assess general fatigue perception
Measured: it will be measured after 8 weeks
six minute walk distance
it will assess distance covered by FMF patients in six minutes of ongoing walking
Measured: it will be measured after 8 weeks
Forced vital capacity
it is a pulmonary capacity test
Measured: it will be measured after 8 weeks
Forced exhalation volume (at first second of exhalation)
it is a pulmonary function testing
Measured: it will be measured after 8 weeks
Ration of Forced exhalation volume (at first second of exhalation) to forced exhalation capacity
it is a pulmonary function testing
Measured: it will be measured after 8 weeks
maximum inhalation pressure
it is indicator for inspiratory muscular strength
Measured: it will be measured after 8 weeks
physical sum of child health qestionnaire
it is an indiactor for physical quality of life
Measured: it will be measured after 8 weeks
mental sum of child health qestionnaire
it is an indiactor for mental quality of life
Measured: it will be measured after 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2025
- Study start10 May 2025
- Primary completion15 Sep 2025 (estimated)
- Study completion15 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Familial Mediterranean FeverStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ali Mohamed Ali ismail, Cairo University
- Investigators
- Ali MA Ismail, lecturer, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07129538
- Sponsor's protocol ID
- IRB00014233-32
- Status last verified
- Aug 2025
- First submitted
- 12 Aug 2025
- Last updated
- 19 Aug 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes of Inspiratory Muscle Training in FMF Adolescents
- ClinicalTrials.gov ID
- NCT07129538
- Acronym / sponsor ID
- IRB00014233-32
- Conditions
- Familial Mediterranean Fever
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 10 May 2025 (actual)
- Primary completion
- 15 Sep 2025 (estimated)
- Study completion
- 15 Sep 2025 (estimated)
- First posted
- 19 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Familial mediterranean fever (FMF) is common to be diagnosed before age of 18 . this disorder is connected with deterioration in exercise tolerance, pulmonary capacities, fatigue tolerance,
Detailed description
Familial mediterranean fever (FMF adolescents ) will be collected to be cateogarized to inspiratory muscle retraining group (IMR group) or control waitlist grouping. every group OF FMF will contain 20 FMF adolescents. IMR group will receive two IMR sessions daily, five times weekly, for eight weeks (every IMR session will contain 3 sets of IMR and the set will contain 10 breath cycles).. both groups will receive their prescribed colchicine medications daily
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IMR group | Experimental | Other: inspiratory muscle retrainingFamilial mediterranean fever (FMF adolescents ) in this inspiratory muscle retraining group (IMR group) will contain 20 FMF adolescents. IMR group will receive two IMR sessions daily, five times weekly, for eight weeks (every IMR session will contain 3 sets of IMR and the set will contain 10 breath cycles).. also this group will receive their prescribed colchicine medications daily |
| control group | Other | Other: colchicine onlyFamilial mediterranean fever (FMF adolescents ) will be group of FMF will contain 20 FMF adolescents. this group will receive their prescribed colchicine medications daily |
Who may qualify
- Ages
- 13 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- FMF adolecents
- ages 13 -17 years
- forty patients
Key exclusion criteria (5 listed)
- cardiac problems
- renal problems
- liver problems
- diabetes
- brain problems
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| inspiratory muscle retrainingFamilial mediterranean fever (FMF adolescents ) will be inspiratory muscle retraining group (IMR group) that will contain 20 FMF adolescents. IMR group will receive two IMR sessions daily, five times weekly, for eight weeks (every IMR session will contain 3 sets of IMR and the set will contain 10 breath cycles).. this group will receive their prescribed colchicine medications daily | Other | IMR group |
| colchicine onlyFamilial mediterranean fever (FMF adolescents ) will be collected in this group OF FMF that will contain 20 FMF adolescents. this group will receive their prescribed colchicine medications daily for eight weeks | Other | control group |
Primary outcome
Multidimensional Scale of Fatigue extracted from total score of pediatric quality of life
Time frame: it will be measured after 8 weeks
it will assess fatigue perception
10 secondary outcomes
cognitive fatigue subscale of Multidimensional Scale of Fatigue related pediatric quality of life
Time frame: it will be measured after 8 weeks
sleep and rest fatigue subscale of Multidimensional Scale of Fatigue related pediatric quality of life
Time frame: it will be measured after 8 weeks
general fatigue subscale of Multidimensional Scale of Fatigue related pediatric quality of life
Time frame: it will be measured after 8 weeks
six minute walk distance
Time frame: it will be measured after 8 weeks
Forced vital capacity
Time frame: it will be measured after 8 weeks
Forced exhalation volume (at first second of exhalation)
Time frame: it will be measured after 8 weeks
Ration of Forced exhalation volume (at first second of exhalation) to forced exhalation capacity
Time frame: it will be measured after 8 weeks
maximum inhalation pressure
Time frame: it will be measured after 8 weeks
physical sum of child health qestionnaire
Time frame: it will be measured after 8 weeks
mental sum of child health qestionnaire
Time frame: it will be measured after 8 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ismail, lecturer contact
Ali MA Ismail, lecturer principal investigator
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing inspiratory muscle retraining and colchicine only in people with Familial Mediterranean Fever, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ali MA Ismail, lecturer (01005154209, ali.mohamed@pt.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Multidimensional Scale of Fatigue extracted from total score of pediatric quality of life (time frame: it will be measured after 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2025.